Treatment of Infertility in Women With Polycystic Ovary Syndrome

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

ClinicalTrials.gov Identifier:

NCT00068861

First Posted: September 11, 2003

Last Update Posted: October 1, 2007

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.

Information provided by:

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Polycystic Ovary Syndrome (PCOS) is a common endocrine disorder affecting up to 10% of women. The primary symptoms of PCOS are menstrual irregularities, increased body and facial hair, acne, and infertility. This study will test a combination of medications in women with PCOS to determine which works best to overcome infertility.

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:

Live birth rate

Secondary Outcome Measures:

singleton live birth rate

ovulation rate

cycles to first ovulation

cycles to conception

abortion rate

cycles to pregnancy

weeks from pregnancy to live birth

Estimated Enrollment:

678

Study Start Date:

November 2002

Study Completion Date:

February 2006

Detailed Description:

PCOS is characterized by excess circulating androgen levels and chronic anovulation. The fundamental pathophysiologic defect is unknown, but PCOS is characterized by insulin resistance and compensatory hyperinsulinemia. Improvements in insulin sensitivity in PCOS women, either through lifestyle changes or through pharmaceutical intervention, have consistently resulted in a marked improvement in the reproductive and metabolic abnormalities in PCOS. Resumption of ovulation occurs in up to 70% of women treated for PCOS. This study will evaluate the safety and effectiveness of clomiphene citrate and metformin XR in achieving a successful pregnancy in infertile PCOS women.

Women with PCOS who are seeking pregnancy will be enrolled in this study. Women will be randomized to one of three different treatment arms: A) metformin XR 1000 mg twice/day; B) clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle); or C) metformin XR 1000 mg twice/day with clomiphene citrate 50 mg/day for 5 days (day 3-7 of cycle). Women will continue on study medications for 30 weeks, 6 treatment cycles, or until they become pregnant. Progesterone levels will be drawn weekly to monitor ovulation.

Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:

18 Years to 39 Years (Adult)

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria

Eight or fewer menstrual cycles in the past year or intermenstrual periods of 45 days or longer

Elevated testosterone level

Good general health

Sperm concentration in partner of 20 million/ml or greater

Ability to have intercourse 2-3 times per week

One functional fallopian tube and normal uterine cavity

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00068861

Locations

United States, Alabama

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35249

United States, California

University of California at San Diego

La Jolla, California, United States, 92037

Stanford University

Stanford, California, United States, 94305

United States, Colorado

University of Colorado

Aurora, Colorado, United States, 80045

United States, Michigan

Wayne State

Detroit, Michigan, United States, 48201

United States, New Jersey

University of Medicine and Dentistry New Jersey

Newark, New Jersey, United States, 07103

United States, Pennsylvania

Penn State

Hershey, Pennsylvania, United States, 17033

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

United States, Texas

University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75390

Baylor College of Medicine

Houston, Texas, United States, 77030

United States, Virginia

Virginia Commonwealth University

Richmond, Virginia, United States, 23298

Sponsors and Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)